Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death).
研究概览
简要总结
The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).
详细描述
This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.
Comparison: External cardioversion vs. catheter ablation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >20 years and <75 years
- •documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter)
- •documented sufficient anticoagulation for at least 4 weeks before inclusion
排除标准
- •Paroxysmal atrial fibrillation
- •NYHA IV (if recompensation is not possible)
- •Contraindication for warfarin
- •Disturbance of blood coagulation
- •Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before
- •Reversible causes of atrial fibrillation (i.e. hyperthyroidism)
- •Pregnancy
- •LA-diameter > 55mm
- •LV-function < 30% EF
- •Aortic or mitral stenosis or regurgitation III°-IV°
- •Prosthetic valves
研究组 & 干预措施
1
catheter ablation to treat persistent atrial fibrillation
干预措施: catheter ablation (Procedure)
2
cardioversion and drug prophylaxis to treat persistent atrial fibrillation
干预措施: external electric cardioversion (Procedure)
结局指标
主要结局
Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death).
时间窗: 6 months
次要结局
- success-rate immediately after intervention(success-rate immediately after intervention)
- need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion)(2-3 months)
- burden of atrial fibrillation in a 7-day-holter after 6 months(6 months)
- significant improvement in exercise capacity (measured by spiroergometry)(6 months)
- decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention(6 months)
- improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up(6 months)